Counterfeit Drugs in America 2017

February 16, 2017

Click on image above to download the PDF of the document.

Counterfeit Drugs in America: Crimes, Victims and Solutions.
Fact Pack, 2nd edition

This page offers direct links to sources cited in the footnotes for the 2017 edition of the Partnership for Safe Medicines’  Counterfeit Drugs in America.  Want copies? Email us at editors@safemedicines.org.

Sources:

(page 4)

  1. “FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs,” U.S. Food and Drug Administration, November 2, 2016, accessed February 2017; “Historical Information: FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs, 2012-2014,” U.S. Food and Drug Administration, November 2, 2016, accessed February 2017; “Proposal to Debar, Notice of Opportunity for Hearing, Docket no. FDA-2010-N-0441,” U.S. Food and Drug Administration, November 16, 2010, accessed February 2017.

(page 6-7)

  1. “FDA Issues Letters to Doctors Who May Have Purchased,” U.S. Food and Drug Administration, November 2, 2016; “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016.

(page 8)

  1. “The dangers of counterfeit medical products,” Interpol, accessed February 2017.
  2. Jocelyn Sambira, “Counterfeit drugs raise Africa’s temperature,” Africa Renewal, May 2013, accessed February 2017.
  3. Alexandra Ossola, “The fake drug industry is exploding and we can’t do anything about it,” Newsweek, September 25, 2015, accessed February 2017,  and “Therapeutic Categories,” Pharmaceutical Security Institute, accessed February 2017.

(page 11)

  1. “7 Most Common Counterfeit Drugs,” Partnership for Safe Medicines, August 23, 2012, accessed February 2017; “Tehachapi Doctor Pleads Guilty to Defrauding Patients and Insurers by Implanting IUDs That Were Not Approved by the FDA,” U.S. Department of Justice, August 24, 2015, accessed February 2017; Christina Jewett and Will Evans, “Medical firm profited on pain with knockoff spine surgery hardware,” Center for Investigative Reporting, November 3, 2014, accessed February 2017; “Owner Of Major Online Colored Contact Lens Business Sentenced to 46 Months in Prison in Largest-Ever Scheme to Import and Sell Counterfeit and Misbranded Contact Lenses Prosecuted in the United States,” U.S. Department of Justice, January 18, 2017, accessed February 2017; “Two South Florida Residents Charged with Conspiring to Misbrand and Sell Expired Gastric Banding Systems,” U.S. Department of Justice, December 9, 2016, accessed February 2017; “Medical Device Distributor Sentenced For Importing, Reselling Counterfeit And Contaminated Surgical Hernia Mesh,” U.S. Food and Drug Administration, May 8, 2012, accessed February 2017.

(page 12)

  1. “FDA Issues Letters to Doctors Who May Have Purchased,” U.S. Food and Drug Administration, November 2, 2016; “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016.

(page 13)

  1. “FDA Issues Letters to Doctors Who May Have Purchased,” U.S. Food and Drug Administration, November 2, 2016; “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016.
  2. Jeanne Whalen, “Turkish drug exporter Ozay draws U.S. scrutiny,” Wall Street Journal, April 2, 2014, accessed February 2017.
  3. “Counterfeit Version of Avastin in U.S. Distribution,” U.S. Food and Drug Administration, February 14, 2012, accessed February 2017; Indictment, USA vs. Canada Drugs, LTD et al, Case 2:14-cr-00027-DLC, U.S. District Court for the District of Montana, July 17, 2015, accessed February 2017.
  4. “Another counterfeit cancer medicine found in U.S. – Illegal practice puts patients at risk,” U.S. Food and Drug Administration, April 3, 2012, accessed February 2017; Jeanne Whalen, “U.S. sentences British citizen for distributing fake Avastin,” Wall Street Journal (Online), July 12, 2013; Matthew Perrone, “FDA finds more vials of fake cancer drug,” The Boston Globe, April 4, 2012, accessed February 2017; and Indictment, USA vs. Canada Drugs.
  5. “Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States,” U.S. Food and Drug Administration, February 5, 2013, accessed February 2017; “Two Officers Of Long Island Based Company Indicted For Sale Of $17 Million Worth Of Misbranded Prescription Drugs Including Counterfeit Cancer Drugs,” U.S. Department of Justice, April 30, 2014, accessed February 2017; Superseding Indictment, USA v William Scully, Case 2:14-cr-00208-ADS-SIL, U.S. District Court, Eastern District of New York, July 22, 2015.

(page 14)

  1. “Letter to Doctors about the Risks of Purchasing Unapproved Versions of Botox and Other Medications from Foreign or Unlicensed Suppliers,” U.S. Food and Drug Administration, November 30, 2012, accessed February 2017; “Letter to Doctors about the Risks of Purchasing Fraudulent Versions of BOTOX from ‘Online BOTOX Pharmacy’ and ‘onlinebotox.com,’” U.S. Food and Drug Administration, July 11, 2013, accessed February 2017; “Letter to Doctors about the Risks of Purchasing Unapproved Drugs from Gallant Pharmaceutical International,” U.S. Food and Drug Administration, April 1, 2015, accessed February 2017; “Letters to Doctors about Counterfeit Botox Distributed by TC Medical,” U.S. Food and Drug Administration, March 21, 2016 and March 30, 2016, accessed February 2017.

(page 15)

  1. “Fraudulent Versions of Botox Found in the United States,“ U.S. Food and Drug Administration, April 26, 2013, accessed February 2017.
  2. “Counterfeit Version of Botox Found in the United States,” U.S. Food and Drug Administration, April 16, 2015, accessed February 2017.
  3. Indictment, USA vs. T.C. Medical, et. al, Case 1:14-cr-00397-AJT, U.S. District Court for the Eastern District of Virginia, December 3, 2014, accessed February 2017.

(page 16)

  1. “Tehachapi Doctor Pleads Guilty,” U.S. Department of Justice, August 24, 2015; “Owensboro Doctor Pleads Guilty in National Medicaid Fraud Investigation,” Tristatehomepage.com, December 21, 2016, accessed February 2017; “Attorney General Conway Announces Sentencing of Grayson County Doctor for Use of Non-FDA Approved Birth Control Device,” Kentucky Office of the Attorney General, August 12, 2013, accessed February 2017; “Owner Of Bluegrass Women’s Healthcare In Elizabethtown Charged With Health Care Fraud, Mail Fraud, Misbranding And Smuggling,” United States Attorney’s Office, Western District of Kentucky, March 21, 2013; “FDA Cautions Against Using Unapproved IUDs,” U.S. Food and Drug Administration, July 22, 2010, accessed February 2017; “Letter to Doctors about Suspect Prescription Drugs Distributed by Medical Device King,” U.S. Food and Drug Administration, May 13, 2013, accessed February 2017.

(page 17)

  1. “Tehachapi Doctor Pleads Guilty,” U.S. Department of Justice, August 24, 2015.
  2. “Owensboro Doctor Pleads Guilty,” Tristatehomepage.com, December 21, 2016.
  3. “FDA Cautions Against,” U.S.Food and Drug Administration, July 22, 2010; “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016.

(page 19)

  1. “Reported Law Enforcement Encounters Testing Positive for Fentanyl Increase Across US,” Centers for Disease Control and Prevention, August 24, 2016, accessed February 2017 and “Counterfeit Prescription Pills Containing Fentanyls: A Global Threat,” U.S. Drug Enforcement Agency, DEA-DCT-DIB-021-16, July 2016, accessed February 2017.
  2. “When Fake Drugs Turn Deadly,” Partnership for Safe Medicines, accessed February 2017.

(page 20)

  1. Erin Wilson, et al. “The Use and Correlates of Illicit Silicone or ‘fillers’ in a Population-Based Sample of Transwomen, San Francisco, 2013,” The Journal of Sexual Medicine, 11.7 (2014): 1717–1724.
  2. “Miss. woman gets life in silicone buttocks injection case,” CBSNews.com, September 2, 2014, accessed February 2017; Kristen Guilfoos, “South Texas woman gets 5 years for client’s Botox death,” KBTX, March 5, 2016, accessed February 2017; David Ovalle, “Police arrest man accused of performing butt injections that killed 28-year-old,” Miami Herald, May 21, 2016, accessed February 2017; Naomi Martin, “Update: Suspect arrested in Dallas butt injections death freed after posting bond,” The Dallas Morning News, June 10, 2015, accessed February 2017.
  3. “Owner Of Major Online Colored Contact Lens Business Sentenced,” U.S. Department of Justice, January 18, 2017, accessed February 2017; Indictment, USA vs. Dmitriy Melnik, Case 2:16-cr-00033-JCM-GWF, U.S. District Court for the District of Nevada, February 3, 2016, accessed February 2017.

(page 21)

  1. “Two South Florida Residents Charged with Conspiring,” U.S. Department of Justice, December 9, 2016; “Tampa-Area Medical Device Salesman Guilty of Selling Expired Lap-Band Devices,” U.S. Department of Justice, January 17, 2017, accessed February 2017; “The Lap-Band Adjustable Gastric Banding System Summary of Safety and Effectiveness Data,” U.S. Food and Drug Administration, accessed February 2017.
  2. Christina Jewett and Will Evans, “Medical firm profited“; Steven Mikulan, “Kickbacks, Bribes, and the Horrifying Truth Behind California’s Largest Medical Fraud Scandal,” Los Angeles Magazine, March 21, 2016.
  3. “Medical Device Distributor Sentenced,” U.S. Department of Justice, May 8, 2012; “FDA Patient Safety News: Show #101, August 2010,” U.S. Food and Drug Administration, accessed February 2017; Phil Taylor, “Lawsuit over counterfeit surgical mesh rumbles on,” Securing Industry, October 5, 2011, accessed February 2017.

(page 22)

  1. Rick Roberts, “Problem of Counterfeit Prescription Drugs,” Partnership for Safe Medicines 2010 Interchange, C-Span, Washington, D.C., October 8, 2010.
  2. “Two Plead Guilty In Prescription Drug Diversion Scheme,” U.S. Department of Justice, May 8, 2014, accessed February 2017; “Pharmacist Sentenced in Manhattan Federal Court to 36 Months in Prison in Multi-Million-Dollar Medicare/Medicaid Fraud Scheme,” U.S. Federal Bureau of Investigation, March 26, 2015, accessed February 2017; “Six Charged In Manhattan Federal Court For Operating Illegal Prescription Drug Ring Out Of Bronx Grocery Store,” U.S. Department of Justice, June 25, 2014, accessed February 2017; “A.G. Schneiderman Announces Sentencing Of Long Island Pharmacist Of Up To 24 Years In Prison For Selling Black-Market HIV Medications,” New York State Office of the Attorney General, October 26, 2016, accessed February 2017; “A.G. Schneiderman Announces Trial Conviction of Pharmacist Who Illegally Sold Black Market HIV Medications,” New York State Office of the Attorney General, August 9, 2016, accessed February 2017; Judgment, USA vs. David Correa, Case 1:13-cr-00289-AKH, U.S. District Court, Southern District of New York, May 28, 2014; Bob LaMendola, “Weston Man Gets Nine Years For Drug Fraud,” Sun-Sentinel, February, 6, 2010, accessed February 2017; Ken Thomas, “Florida grand jury indicts 19 on prescription fraud,” St. Augustine Record, July 22, 2003, accessed February 2017; “April 23, 2009: Pharmacist is Sentenced for Illegally Buying and Selling Pharmaceuticals, Defrauding Health Insurers,” U.S. Food and Drug Administration, accessed February 2017; Mike McKinney, “Cranston pharmacist sentenced in insurance scheme,” Providence Journal (RI), April 23, 2009 via NewsBank, accessed February 2017; Mike McKinney, “Pharmacist, 73, Providence man, 81, face drug charges.” Providence Journal (RI), May, 6 2008, via NewsBank, accessed February 2017; “February 18, 2010: Miami Prescription Drug Diverter Sentenced to 70 Months in Prison,” U.S. Food and Drug Administration, accessed February 2017; “Miami drug distributor sentenced,” South Florida Business Journal, February 18, 2010, accessed February 2017; “January 27, 2009: Robert McFadden, Palm Springs Attorney, Convicted in Prescription Drug Diversion Trial,” U.S. Food and Drug Administration, accessed February 2017; “June 4, 2009: California Man Sentenced for Prescription Drug Diversion,” U.S. Food and Drug Administration, accessed February 2017; Albert McKeon, “Reselling drugs leads to prison term,” The Nashua Telegraph, June 19, 2010, accessed February 2017.

(page 23)

  1. Anna W. Mathews, “So Young and So Many Pills,” Wall Street Journal, December 28, 2010, accessed February 2017.
  2. “Texas Children Given Fake Antibiotics,” Houston Chronicle, April 29, 2012, accessed February 2017.
  3. Vickie Chachere, “Attorney General Sues Tampa Couple over Fake Cystic Fibrosis Drug,” The Florida Times-Union, April 7, 2005, accessed February 2017.
  4. “FDA Warns Consumers about Counterfeit Version of Teva’s Adderall,” U.S. Food and Drug Administration, May 29, 2012, cached copy, accessed on FDA website in February 2017.

(page 24)

  1. “Beware of Fraudulent Flu Products,” U.S. Food and Drug Administration, February 15, 2013, accessed February 2017.
  2. “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016; “Local Physician and Clinic Sentenced on Health Care Related Charges,” U.S. Department of Justice, September 2, 2015, accessed February 2017; “Louisville Physician Pays $515,408.85 For Treating Patients With Misbranded Drugs And Fraudulently Charging Medicare,” U.S. Department of Justice, January 29, 2015, accessed February 2017; “Dickson, Tennessee Medical Practice To Pay More Than Half A Million Dollars To Settle False Claims Act Allegations,” U.S. Department of Justice, February 23, 2015, accessed February 2017.

(page 25)

  1. “FDA Warns Consumers about,” U.S. Food and Drug Administration, May 29, 2012.
  2. “FDA Warns Consumers about Counterfeit Alli,” U.S. Food and Drug Administration, January 18, 2010, cached copy last accessed on FDA website in February 2017; “Chinese National Sentenced to Federal Prison for Trafficking Counterfeit Pharmaceutical Weight Loss Drug,” U.S. Department of Justice, June 3, 2011, accessed February 2017; Decision, USA vs. Shengyang Zhou, No. 11–1261, United States Court of Appeals, Tenth Circuit, June 10, 2013.

(page 26)

  1. Lethal Fake Medicine, Morten Krøgholt, Bullitt Film, 2016, accessed February 2017; “Another counterfeit cancer medicine found,” U.S. Food and Drug Administration, updated July 10, 2012.
  2. Jeanne Whalen, “Second turkish man pleads guilty to smuggling fake cancer drugs,” Wall Street Journal, August 13, 2014, accessed February 2017.

(page 27)

  1. Alexandra Koehn, “Local Woman Dies After Taking Counterfeit Xanax,” Scripps Media, Inc., February 10, 2016, cached at the Internet Archive and “Family says woman died after overdosing on fake prescription pills,” WSMV (Meredith Corporation), February 22, 2016, accessed February 2017.
  2. “The Possible Dangers of Buying Medicines over the Internet,” U.S. Food and Drug Administration, January 16, 2005, accessed February 2017.

(page 28)

  1. “Miss. woman gets life,” CBSNews.com, September 2, 2014; Kristen Guilfoos, “South Texas woman gets 5 years,” KBTX, March 5, 2016; David Ovalle, “Police arrest man,” Miami Herald, May 21, 2016; Naomi Martin, “Update: Suspect arrested,” The Dallas Morning News, June 10, 2015; “Soft Tissue Fillers (Dermal Fillers),” U.S. Food and Drug Administration, updated June 26, 2015, accessed February 2017.
  2. Alex Charles Essenmacher and Seyed Amin Astani, “Respiratory Disease following Illicit Injection of Silicone: A Case Report,” Case Reports in Medicine, June 23, 2013, accessed February 2017.
  3. “Black Market Cosmetic Injectables in the U.S., 2005 – 2013,” Partnership for Safe Medicines, accessed February 2017; “Business Pleads Guilty to $3 Million Scheme to Sell Foreign Versions of Botox,” U.S. Department of Justice, June 5, 2014, accessed February 2017; “Pharr Woman Sentenced in Liquid Silicone Injection Case,” U.S. Food and Drug Administration, October 5, 2015, accessed February 2017; Lorenzo Zazueta-Castro, “Probation for woman convicted in injection case,” The Monitor, November 15, 2016, accessed February 2017; Kristian Hernandez, “Spa owner sentenced to 5 years for killing woman with fake botox injections,” The Monitor, March 4, 2016, accessed February 2017; “Bellevue salon owner sentenced to 13 months in prision in connection with unlicensed cosmetic treatments,” U.S. Department of Justice, January 15, 2010; “Canadian Companies Fined $45 Million and Ordered to Forfeit an Additional $30 Million for Smuggling Misbranded Pharmaceuticals into the United States,” U.S. Department of Justice, August 21, 2015, accessed February 2017; “Two Canadians Sentenced for Distributing Counterfeit and Adulterated Botox to Local Doctors,” U.S. Department of Justice, August 4, 2015, accessed February 2017; “Greenville Medical Practice Receives Probationary Sentence and Agrees to Pay $300,000 to the United States,” U.S. Department of Justice, August 29, 2016, accessed February 2017; “Nurse Who Operated Spa in Laguna Niguel Agrees to Plead Guilty to Illegally Dispensing Botox Not Approved for Use in United States,” U.S. Department of Justice, November 10, 2016, accessed February 2017; “Physician’s Assistant Pleads Guilty to Violating Federal Food, Drug and Cosmetic Act,” U.S. Department of Justice, December 1, 2016, accessed February 2017.

(page 29)

  1. Daniel Burke, “The Impacts of Fake Online Pharmacies on Patient Safety,” Partnership for Safe Medicines Interchange 2014, Washington, D.C., September 18, 2014.

(page 31)

  1. The drugs Gallant sold, as listed in the FDA’s April 1, 2015 letter to medical practices who were their customers, treat these conditions. “More than 39 Unapproved Drugs Purchased from Gallant Pharmaceutical International or Gallant Medical International,” U.S. Food and Drug Administration, April 1, 2015, accessed March 2017.
  2. “More than 39 Unapproved Drugs Purchased,” U.S. Food and Drug Administration, April 1, 2015.
  3. “Illegal Drug Company Gallant Pharma And Co-Founder Sentenced,” U.S. Department of Justice, March 7, 2014, accessed March 2017.
  4. “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016; “Illegal Drug Company Gallant,” U.S. Department of Justice, March 7, 2014; ”Eleven Charged In Alleged Illegal Pharmacological Import And Distribution Scheme,” U.S. Department of Justice, August 7, 2013, accessed March 2017; Indictment, USA vs. Gallant Pharmaceutical, Inc, et al., Case 1:13-cr-00130-CMH, U.S. District Court for the Eastern District of Virginia, filed March 27, 2013, accessed February 2017; “Owner Of McLean MedSpa Sentenced For Illegally Importing Non-FDA-Approved Drugs And Using On Patients,” U.S. Department of Justice, July 18, 2014, accessed February 2017. 

(page 32)

  1. “The Fifth Element of Authentication: Condition Monitoring Temperatures of Cold Chain Drugs Ensure Efficacy, Safety and Brand Integrity,” Sensitech Cold Chain Visibility, Accessed February 2017; Indictment, USA vs. TC Medical, et al., Case 1:14-cr-00397-AJT, U.S. District Court for the Eastern District of Virginia, December 3, 2014, accessed March 2017.
  2. “Canadian Company and Drop Shipper Plead Guilty to Conspiracy to Smuggle and Sell Misbranded Prescription Pharmaceuticals,” U.S. Department of Justice, May 7, 2015, accessed March 2017; Indictment, USA v TC Medical, et al.

(page 33)

  1. Jeanne Whalen, “Turkish Drug Exporter Ozay”; “Alert: Suspect Prescription Drugs Distributed by Medical Device King,” Letter from Thomas J. Christi, Acting Director, Office of Drug Security, Integrity, and Recalls, U.S. Food and Drug Administration, accessed March 2017; “List of doctors or clinics purchasing from Medical Device King that received 5/13/2013 letter from FDA,” U.S. Food and Drug Administration, accessed March 2017; and Superseding Indictment, USA vs. William Scully,  Memorandum of Decision and Order, USA vs. William Scully, Case 2:14-cr-00208-ADS-SIL, U.S. District Court, Eastern District of New York March 16, 2016, accessed March 2017.
  2. Memorandum of Decision and Order, USA vs. William Scully.
  3. “President Of Pharmaceutical Companies Sentenced To 60 Months In Prison For Long-Running Scheme To Sell Misbranded And Unapproved Chemotherapy And Other Prescription Drugs,” U.S. Department of Justice, June 2, 2016, accessed March 2017.

(page 34)

  1. Indictment, USA vs. TC Medical, et al.; “Canadian Companies Fined $45 Million and Ordered to Forfeit an Additional $30 Million for Smuggling Misbranded Pharmaceuticals into the United States,” U.S. Department of Justice, August 21, 2015, accessed March 2017.

(page 35)

  1. “June 18, 2014: Somerset Oncology Practice and Office Manager Plead Guilty to Food, Drug and Cosmetic Act Offenses Related to Misbranded Cancer Treatment Drug,” U.S. Food and Drug Administration, June 18, 2014, accessed March 2017; Christopher Weaver and Jane Whalen, “How Fake Cancer Drugs Entered U.S.,” Wall Street Journal, July 20, 2012, accessed February 2017. 

(page 36)

  1. Christopher Weaver and Jane Whalen, “How Fake Cancer Drugs Entered U.S.”

(page 37)

  1. “April 24, 2013: Paul Daniel Bottomley Pleads Guilty in U.S. Federal Court,” U.S. Food and Drug Administration, April 24, 2013, accessed February 2017; “Counterfeit Version of Avastin,” U.S. Food and Drug Administration; “Canadian pharmacy sold unapproved and counterfeit drugs online, U.S. alleges,” The Guardian, August 10, 2015, accessed February 2017; “Purchasing Medications from Foreign or Unlicensed Suppliers Could Result in Serious Harm to Patients; Another Counterfeit Found in U.S.,” Letter from S. Leigh Verbois, Ph.D., U.S. Food and Drug Administration, April 5, 2012, accessed March 2017; “English Citizen Sentenced For Distributing Adulterated And Counterfeit Cancer Drugs,” U.S. Department of Justice, July 11, 2013, accessed February 2017; “Historical Information: FDA Issues Letters to Doctors,” U.S. Food and Drug Administration, November 2, 2016.
  2. John Horton, “CanadaDrugs.com Indictment Exposes Fake Drug Sales, PharmacyChecker Role,” Legitscript, August 18, 2015, accessed February 2017; “Archive list of Not Recommended Sites,” National Association of Boards of Pharmacy, accessed February 2017; “June 18, 2014: Somerset Oncology Practice,” U.S. Food and Drug Administration, June 18, 2014. 

(page 38)

  1. See, for example, Christopher Weaver, “U.S. Fake-Drug Probe Puts Spotlight on Role of Doctors,” Wall Street Journal, November 20, 2012, accessed February 2017.
  2. “Doctors Prosecuted for Buying Misbranded or Counterfeit Prescription Medicines, 2005—,” Partnership for Safe Medicines, accessed February 2017; Order Imposing Restitution Award, USA vs. Paul S. Singh, Case 1:15-cr-00212-AWI, U.S. District Court, Eastern District of California, July 26, 2016; “Lodi Oncologist and Office Administrator Pay $300,000 to Settle False Claims Act Allegations,” U.S. Department of Justice, May 9, 2016, accessed February 2017; “Iowa doctor settles allegations that he recklessly billed for cancer drugs and visits that never happened,” North Iowa Today, November 29, 2016, accessed February 2017; “Greenville Medical Practice Receives,” U.S. Department of Justice, August 29, 2016; “Office Manager For Chattanooga Cancer Treatment Center Pleads Guilty To Ordering Drugs Not Approved By The FDA,” The Chattanoogan, August 2, 2016, accessed March 2017.

(page 39)

  1. “Local Physician and Clinic Sentenced on Health Care Related Charges,” U.S. Department of Justice, September 2, 2015, accessed February 2017.
  2. “Johnson City Physician Sentenced To Serve Two Years In Prison For Unapproved Foreign Drugs,” U.S. Department of Justice, June 11, 2013, accessed February 2017.

(page 40)

  1. “Counterfeit Version of Avastin,” U.S. Food and Drug Administration, February 14, 2012; Indictment, USA vs. D. Anda Norbergs, Case 8:15-cr-00183-JSM-AEP, U.S. District Court, Middle District of Florida, May 28, 2015, accessed March 2017; “Palm Harbor Oncologist Convicted Of Buying Unapproved Cancer Medications From Foreign Sources And Defrauding Medicare,” U.S. Department of Justice, November 18, 2016, accessed February 2017.
  2. “Owner Of McLean MedSpa Sentenced,” U.S. Department of Justice, July 18, 2014.

(page 41)

  1. Lana Vanitskaya, et al, “Dirt Cheap and Without Prescription: How Susceptible Are Young U.S. Consumers To Purchasing Drugs From Rogue Internet Pharmacies?” Journal of Medical Internet Research, 2010;12(2): E11; Tim Mackey and Bryan Liang, “Global Reach Of Direct-To-Consumer Advertising Using Social Media For Illicit Online Drug Sales,” Journal of Medical Internet Research, September 12, 2013, 15(5):E105; and Bryan Liang, Tim Mackey, and Kimberly Lovett, “Illegal “No Prescription” Internet Access To Narrow Therapeutic Index Drugs,” Clinical Therapeutics, April 15, 2013, S0149-2918(13)00167–7.

(page 44)

  1. “Questions and Answers for Consumers,” National Association of Pharmacy Regulatory Authorities, accessed March 2017.
  2. See, for example, Diane C. Gorman, Assistant Deputy Minister of Health Canada in 2004: “Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future,” quoted in the HHS Task Force on Drug Importation Report on Prescription Drug Importation, December 2004, accessed February 2017.
  3. Dan, Mangan, “Canada pharmacy charged in $78M drug export scheme,” CNBC, August 19, 2015, accessed February 2017; “FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs,” U.S. Food and Drug Administration, September 28, 2016, accessed February 2017.
  4. “Counterfeit Medicine,” U.S. Food and Drug Administration, August 12, 2016, accessed February 2017.

(page 45)

  1. “Canada’s population estimates, first quarter 2016,” Statistics Canada, accessed February 2017, and Rob Schlesinger, “The Size of the U.S. and the World in 2016,” U.S. News and World Report, January 5, 2016, accessed February 2017.
  2. “Statement of the Canadian Arthritis Patient Alliance On Minnesota Legislation to Import Medication from Canadian Pharmacies,” accessed February 2017.

(pages 46-47)

  1. Kenneth “Mac” McCall, “Panel 3: The Impacts of Fake Online Pharmacies on Patient Safety,” Partnership for Safe Medicines Interchange 2014, Washington DC, September 18, 2014.

(pages 48-49)

  1. Dr. Robert M. Califf, “Questions for the Record,” HELP Committee Hearing on the Nomination of Dr. Robert Califf to serve as FDA Commissioner, November 17, 2015.
  2. “FDA Issues 22 Warning Letters to Website Operators,” U.S. Food and Drug Administration, November 19, 2009.
  3. Testimony of Dr. Andrew Von Eschenbach, FDA Commissioner, before the House Energy and Commerce Committee, Subcommittee on Oversight & Investigations, January 29, 2008.
  4. Letter to President Clinton from HHS Secretary Shalala, December 26, 2000, cited in the debate about S.1082, on May 3, 2007, 110th Cong.,1st sess., pt 8: 11247.
  5. Tommy Thompson, Secretary of Health and Human Services, testimony before the Senate Budget Committee, February 14, 2002, quoted in Examining Prescription Drug Importation: A Review of a Proposal to Allow Third Parties to Reimport Prescription Drugs, Hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, July 25, 2002, 107th Congress., 2nd Sess.,, Serial No. 107-13.

(page 50)

  1. Letter from Carmen A. Catizone, Executive Director of the National Association of Boards of Pharmacy, February 10, 2017, accessed February 2017.

(page 52)

  1. “Save Money on Meds: 6 Tips for Finding the Best Prescription Drug Prices,” Consumer Reports, January 05, 2016, accessed February 2017.

(page 58)

  1. Data collected at “Doctors Prosecuted for Buying Misbranded or Counterfeit Prescription Medicines, 2005—,” Partnership for Safe Medicines.
  2. Kirill Levchenko, et al.,”Click Trajectories: End-to-End Analysis of the Spam Value Chain,” Proceedings of the 2011 IEEE Symposium on Security and Privacy, 431-446.

(page 59)

  1. Becky Campbell, “Johnson City cancer center manager gets probation for role in mislabeled drugs case,” Johnson City Press, April 1, 2013, accessed February 2017.
  2. “Clinic Manager Sentenced For Receiving Misbranded Botox,” U.S. Department of Justice, March 28, 2014, accessed February 2017.
  3. “Lodi Oncologist and Office Administrator Pay,” U.S. Department of Justice, May 9, 2016.
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